A Phase I Study of Ganetespib +/- Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to find out what effects, good and/or bad, that ganetespib and bortezomib has on you and your cancer. The investigators will determine the side effects of different dose levels of ganetespib when given alone and the effect it has on your cancer alone. The investigators will also determine the side effects of ganetespib at different dose levels when given in combination with bortezomib and the effect the combination has on your cancer. The study will measure levels of the drug in your blood and bone marrow as well.
Bortezomib is a proteasome inhibitor that is approved by the US Food and Drug Administration (FDA) that is used for the treatment of multiple myeloma. The brand name for bortezomib is Velcade®.
Ganetespib is considered "investigational" because it has not received approval from the Food and Drug Administration for general use, although it has been previously tested in humans.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Ganetespib +/- Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma|
- maximum tolerated dose (MTD) of ganetespib in combination with bortezomib and dexamethasone. [ Time Frame: 30 days after final cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Ganetespib + Bortezomib+Dexamethasone
Ganetespib IV Days 1, 4, 8, 11 every 3 weeks Cohort1:100 mg/m2, Cohort2:100mg/m2, Cohort3:120 mg/m2, Cohort 4:144 mg/m2,Cohort 5:173 mg/m2.
Bortezomib IV Days 1, 4, 8, 11*every 3 weeks Cohort1:1.0 mg/m2, Cohort 2,3,4,5:1.3 mg/m2
Dexamethasone Oral Prior to Bortezomib Cohort1,2,3,4,5 :20 + 20 mg (Day of and following bortezomib)
standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.Drug: Bortezomib
Standard 3+3 Design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.Drug: Dexamethasone
Standard 3+3 Design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.
|Contact: Sagar Lonial, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02215-5450|
|Principal Investigator: Paul Richardson, MD|
|United States, New York|
|Mount Sinai Medical Center||Not yet recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Sundar Jagannath, MD|
|United States, Ohio|
|Ohio State University||Not yet recruiting|
|Columbus, Ohio, United States, 43210|
|Principal Investigator: Craig Hoffmeister, MD|
|Principal Investigator:||Sagar Lonial, MD||Emory University Winship Cancer Institute|